From the Guidelines
Nimesulide is not considered safe for routine use due to its association with serious liver toxicity. It is a non-steroidal anti-inflammatory drug (NSAID) that has been banned or severely restricted in many countries including the United States, United Kingdom, Australia, and several European nations. In countries where it remains available, nimesulide is typically indicated for short-term treatment of acute pain, symptomatic treatment of osteoarthritis, and management of primary dysmenorrhea (painful menstruation) 1. The typical adult dosage in countries where it's still permitted is 100 mg twice daily, with treatment duration strictly limited to a maximum of 15 days to minimize liver risk. Nimesulide should never be used in children under 12 years, patients with liver impairment, alcoholism, or concurrent use of other hepatotoxic medications. It works by inhibiting COX-2 enzymes more selectively than COX-1, reducing inflammation and pain while potentially causing fewer gastrointestinal side effects than traditional NSAIDs. However, its risk of idiosyncratic liver injury outweighs potential benefits when safer alternatives like ibuprofen, naproxen, or celecoxib are available, as these alternatives have a more favorable risk-benefit profile as noted in studies on NSAID safety and efficacy 1. Patients taking nimesulide should immediately stop and seek medical attention if experiencing symptoms of liver problems such as nausea, vomiting, abdominal pain, fatigue, dark urine, or yellowing of skin/eyes. Key considerations for the use of any NSAID, including nimesulide, involve weighing the risks of gastrointestinal, cardiovascular, and renal complications against the potential benefits of pain relief, as outlined in guidelines for the management of conditions like ankylosing spondylitis 1. Given the availability of safer alternatives and the potential for significant adverse effects, the use of nimesulide should be approached with caution and generally avoided in favor of other NSAIDs with better safety profiles.
From the Research
Safety of Nimesulide
- Nimesulide is associated with a higher risk of hepatotoxicity compared to other NSAIDs, with an adjusted odds ratio (OR) of 2.10 [95% CI 1.28-3.47] 2.
- The risk of hepatotoxicity increases with the length of exposure and higher doses of nimesulide 2.
- A study found that nimesulide is associated with a relatively low occurrence of adverse drug reactions, especially in the gastrointestinal tract, while those in the liver are within or below the general incidence with other NSAIDs 3.
- However, another study found that nimesulide-induced liver injury (nimesulide-DILI) affects mainly women and presents typically with a hepatocellular pattern, and is associated with acute liver failure (ALF) and death in a high proportion of patients 4.
Indications for Usage
- Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) used for its anti-inflammatory, analgesic, and antipyretic properties.
- It is commonly used to treat pain, inflammation, and fever in conditions such as osteoarthritis, rheumatoid arthritis, and other inflammatory diseases.
- However, due to its potential hepatotoxicity, the use of nimesulide should be carefully considered and monitored, especially in patients with pre-existing liver disease or those taking other medications that may increase the risk of liver damage 5, 6.
Risk Factors
- Women and people aged more than 50 years may be at higher risk of drug-induced liver injury from nimesulide 6.
- The type of arthritis and the presence of other medical conditions may also increase the risk of hepatotoxicity 6.
- Patients taking nimesulide should be aware of the potential risks and monitor their liver function regularly, especially if they are taking high doses or have a history of liver disease 4.